Fda Dietary Supplement Facility Registration
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The fda food safety modernization act fsma enacted on january 4 2011 amended section 415 of the federal food drug and cosmetic act fd c act in relevant part to require that facilities.
Fda dietary supplement facility registration. The dietary supplement health and education act of 1994 gives the fda jurisdiction over these products which are treated as foods. The food safety modernization act fsma now requires biennial registration renewal to be done every even numbered year. This page contains links with information on how to register a food facility.
Facilities that manufacture pack or hold dietary supplements for u s. Fda registration is required for all facilities that manufacture process pack or store dietary supplements that may be consumed in the united states by humans or animals. Companies located outside the united states must designate a u s.
Facilities located outside of the united states must designate a u s. Agent for fda communications at the time of registration. As part of the provisions of the bioterrorism act of 2002 food facilities are required to register with fda.
Fda requires supplement facilities to renew their registrations between october 1 and december 31 of each even. The fda requires all domestic and foreign facilities that manufacture process pack or hold dietary supplements for importation or distribution in the united states to register with the fda. Dietary supplements manufacturers storage facilities and packers are subject to fda regulations under fda food facility registration rules.
Dietary supplement includes proteins amino acids fats and lipid substances vitamins minerals animal by products and.
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